What is FDA product code NVP?

Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles

Anesthesiology › TherapeuticHolding Chambers, Direct Patient Interface

Respichamber* VHC With Mouthpiece

Name: Respichamber* VHC with Mouthpiece
Brand: Respichamber* VHC with Mouthpiece

RespiChamber VHC is a valved holding chamber used with most pressurized metered-dose inhalers prescribed by a healthcare professional. It delivers aerosolized medication to patients who…

Registry build 21.09.26

RespiChamber VHC is a valved holding chamber used with most pressurized metered-dose inhalers prescribed by a healthcare professional. It delivers aerosolized medication to patients who breathe spontaneously, under the care of a licensed provider, at home, in a hospital or in a clinic.

After the inhaler is actuated, a one-way valve holds medication particles in the chamber for several seconds so the patient can inhale them. The chamber is designed to limit delivery of larger particles to the mouth, throat and upper airway while allowing smaller therapeutic particles to be inhaled.

Listed Item

RESPICHAMBER™ VHC with Mouthpiece

Patient Use

The chamber is a nonsterile, disposable device for use by one patient. It is supplied by prescription.

3manufacturers in China registered for this device type

1catalogue number

6510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NVP
Manufacturer	City	Province	Registered as	Device types
Flexicare Medical (Dongguan) Ltd.	Dongguan	Guangdong	Contract manufacturer	48
Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
Koo (Shanghai) Industries Co., Ltd.	Songjiang	Shanghai	Contract manufacturer	9

Record

Regulatory record for Respichamber* VHC with Mouthpiece
Listed by	Trudell Medical International, Canada
FDA product code	NVP
Device type	Holding Chambers, Direct Patient Interface
Device class	Class 2
Regulation	21 CFR 868.5630
Establishment	Specification developer, Manufacturer
510(k)	K110136
Record published	2024-03-11

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number
Packaging	Pack of 100

Catalogue Numbers

Catalogue numbers for Respichamber* VHC with Mouthpiece
Catalogue number	Size	Status
101533		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aerochamber Plus® Flow-Vu®	Monaghan Medical Corp.	23
OptiChamber Diamond	Respironics Respiratory Drug Delivery (Uk), Ltd.	8
InspiraChamber Valved Holding Chamber	Inspirx, Inc.	8
Aerochamber Plus® Z Stat®	Monaghan Medical Corp.	5
Monaghan™ Z Stat®	Monaghan Medical Corp.	5
InspiraChamber®	Clement Clarke Intl., Ltd.	5
VentiChamber	Clement Clarke Intl., Ltd.	5
Clever Choice	Simple Diagnostics	3
Flexichamber	Avadel Pharmaceuticals (USA), Inc.	2
Breathe Comfort	Slv Pharmaceuticals LLC	2
Flexichamber	Cerecor Inc.	2
InspiraChamber®	Flexicare Medical Ltd.	2

Showing 12 of 38. All products under Holding Chambers, Direct Patient Interface

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K242667	2025-01-15
K181649	2019-01-11
K112010	2012-07-11
K110136	2011-04-18
K070674	2007-04-11
K052332	2005-09-21

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.